Status:
COMPLETED
Adjuvant HIPEC in High Risk Colon Cancer
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Health Care Insurance Board
Conditions:
Colorectal Neoplasms
Peritoneal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of a T4 or intra-abdominal...
Detailed Description
Background: The peritoneum is the second most common site of recurrence in patients with colon cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult and adjuvant systemic ...
Eligibility Criteria
Inclusion
- age between 18 and 75 years
- Intention to start routine adjuvant systemic therapy
- adequate clinical condition to undergo simultaneous HIPEC or re- laparoscopy or re-laparotomy with HIPEC within either 10 days or between week 5-8 from --primary resection
- written informed consent
- white blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
- no bleeding diathesis or coagulopathy
- normal creatinine or creatinine clearance of at least 50 ml/min
Exclusion
- postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula)
- no intention to start routine adjuvant systemic therapy
- liver and/or lung metastases
- pregnant or lactating women
- unstable or uncompensated respiratory or cardiac disease
- serious active infections
- other concurrent chemotherapy
- hypersensitivity to fluorouracil, folinic acid or another substance of leucovorin or oxaliplatin
- stomatitis, ulceration in the mouth or gastrointestinal tract.
- severe diarrhea
- severe hepatic and / or renal dysfunction.
- plasma bilirubin concentrations greater than 85 μmol/l.
- pernicious anemia or other anaemias due to vitamin B12 deficiency.
- peripheral sensory neuropathy with functional impairment.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02231086
Start Date
March 1 2015
End Date
June 1 2019
Last Update
September 16 2021
Active Locations (9)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
2
Antoni van Leeuwenhoek hospital
Amsterdam, Netherlands
3
Free University Medical Center
Amsterdam, Netherlands
4
Catharina hospital
Eindhoven, Netherlands